Article of manufacture for anatomical support, pain reduction, or therapeutic treatment

ABSTRACT

A method for manufacturing stretch resistant plantar fascia support system is provided. The stretch resistant plantar fascia support system is adhesively applied to the foot of a patient for providing relief from plantar fasciitis. A portion of the stretch resistant plantar fascia support system is adhesively attached to the bottom surface of the foot for reducing stress on the plantar fascia.

RELATED APPLICATIONS

This application is a continuation of and claims priority of U.S. patentapplication Ser. No. 11/165,304, filed Jun. 23, 2005, which is aContinuation-in-Part and claims priority of U.S. patent application Ser.No. 10/817, filed Apr. 2, 2004 titled “System For Treatment of PlantarFasciitis”, and the contents of these applications are incorporatedherein by reference in their entirety.

BACKGROUND OF THE INVENTION

The present invention generally relates to a stretch resistant plantarfascia support system. More particularly, the present invention relatesto a stretch resistant plantar fascia support system that may beadhesively applied to a foot to provide relief from plantar fasciitis.

FIG. 1 is a dissected bottom view of a human foot 100 provided toillustrate some of the parts of a plantar fascia 110 located in thebottom of the human foot 100. As shown in FIG. 1 , the plantar fascia110 extends from about the location of the heel 101 to about thelocation of the ball 102 of the foot. The plantar fascia 110 includesmedial plantar fascia 120, superficial tracts 130, a central componentof the plantar fascia 140, and a lateral component of the plantar fascia150. The separate portions of the plantar fascia 110 act as a shockabsorber while walking and transfer tensile forces along the bottom ofthe foot 100.

FIG. 2 illustrates a simplified side view of tissue and bone structurein the human foot 100. As shown in FIG. 2 , the human foot 100 includesthe plantar fascia 110, a plantar calcaneus 160, a talus 162, anavicular 164, a cuneiform 166, a cuboid 168, metatarsals 170, phalanges172, a sesamoid 174, a fat pad area 176, and an outer skin surface 178.From the side view in FIG. 2 , the plantar calcaneus 160, the talus 162,the navicular 164, the cuneiform 166, the cuboid 168, the metatarsals170, and the sesamoid 174 form what resembles the shape of an arch. Thisshape is commonly referred to as the longitudinal arch. Another archcommonly referred to as the transverse arch (metatarsal) also exists inabout the same area in a perpendicular direction that runs laterallyacross the width of the foot.

The plantar fascia 110 serves the vital role of maintaining the shape ofthe two anatomical arches of the foot, the transverse arch and thelongitudinal arch. As illustrated in FIGS. 1 and 2 , the plantar fascia110 runs across the bottom of the foot 100 from the heel 101 to the ball102 and spreads out across the width of the foot 100. As longitudinaland lateral tensile stresses are produced in the bottom of the foot 100,the plantar fascia 110 absorbs the tensile forces and maintains theshape of the two anatomical arches.

For example, while standing or while in motion, forces experienced bythe foot 100 act in a direction which tends to flatten the arches. Thestress line 300 in FIG. 2 shows an approximation of the line of forcestransferred through foot 100 during typical motion. As shown in FIG. 2 ,the stress line 300 resembles the shape of an archer's bow. The plantarfascia 110 running along near the bottom surface of the foot 100 isanalogous to a string in the archer's bow. Forces that tend to move theends of the bow apart increase tension on the string. In other words, asforces on the arch push the bones downward, the plantar fascia 110 issubjected to tensile forces.

If the tension on the plantar fascia 110 becomes excessive, the plantarfascia 110 may be damaged and produce a condition called plantarfasciitis. Plantar fasciitis is a painful medical condition resultingfrom inflammation of the plantar fascia 110. The plantar fascia 110 isthick and essentially inelastic. Overstressing the plantar fascia 110may produce tears in the plantar fascia 110 or separate the plantarfascia 110 from bone and other surrounding materials. Tearing andseparation of the plantar fascia 110 produces the painful inflammationknown as plantar fasciitis. Frequently, the inflamed areas 305 are alongthe arch of the foot 100 or near the heel 101 of the foot 100 as shownin FIG. 2 .

Plantar fasciitis may be quite debilitating in that everyday activitiessuch as walking and standing may be very painful. Typical treatments forplantar fasciitis may involve oral anti-inflammatories, ice packs,bedrest, stretching, steroid injections, night splints and wedge-shapedarch supports. In extreme cases, treatment of plantar fasciitis mayrequire corrective surgery.

For example, a design for an orthotic device for treatment of plantarfasciitis is disclosed in Gleason, U.S. Pat. No. 5,865,779. The deviceof Gleason is an elastic sock that is worn on a patient's foot. Theelastic sock exerts compressive forces along the longitudinal andtransverse axes of the patient's foot.

While some patients may be willing to wear an elastic sock, the elasticsock is both inconvenient and cumbersome. In order to be installed onthe foot, the elastic sock must be stretched to fit over the heel andtoe of the foot. Because the sock is elastic, the sock allows the footto move and stretch. Consequently, the plantar fascia may still besubjected to excessive tensile forces during the critical heelingprocess. Re-subjecting the plantar fascia to tensile forces before ithas completely healed may re-aggravate damaged portions of the plantarfascia and undermine the healing process.

In addition, the elastic sock is meant to be worn multiple times and mayrequire regular cleaning to avoid odors and foot infections. Also, thesock may not fit inside a shoe while being worn and may be consideredunsightly while walking around with bare feet. Consequently, the elasticsock does not prevent excessive stretching of the plantar fascia and isboth inconvenient and cumbersome.

Another typical example of treatment for plantar fasciitis includesmedical personnel strapping strips of tape to the bottom of an injuredfoot. Strips of tape are applied at various angles across the bottom ofthe foot. The tape is difficult to remove from the rolls and bunches upduring the taping process. Thus, care must be exercised during theapplication of the tape to avoid blister-causing wrinkles in the tapeand other problems.

As the patient walks with the taped foot, the tape works loose andstretches with time. In addition, the tape cannot be effectively appliedby the patient to the patient's own foot and requires application byanother individual such as a trained medical technician. Consequently,taping the foot is cumbersome, inefficient, and ineffective inpreventing excessive stretching of the plantar fascia.

Sometimes when current methods of treatment for plantar fasciitis areineffective, expensive surgical procedures are required to relieve thepain of plantar fasciitis. To get at the plantar fascia, surgeons mayperform either an endoscopic procedure requiring small incisions orconventional direct visualization requiring the underside of the foot tobe opened up. With either painful procedure, scars may result andrecovery time may be from weeks to months.

Even with treatment, improper treatment of plantar fasciitis may lead toother medical problems. For example, if inflammation near the heel isallowed to continue for a long period of time, calcium deposits maybuild-up in the damaged region. As the calcium builds-up, bonyoutcroppings may develop in the heel that are commonly referred to as“heel spurs”. The longer the plantar fascia remains inflamed around theheel, the stronger the conditions are for the development of heel spurs.Protrusion of the heel spurs into the surrounding tissue may result in acycle of irritation, inflammation, and pain known as heel spur syndrome.

Heel spur syndrome is commonly treated with a surgical procedurerequiring removal of the heel spurs from within the foot. An endoscopicprocedure is typically not used for removal of heel spurs and opensurgery is typically required. Recovery time from such surgery may rangefrom weeks to months, during which time the patient has to curtail theamount of stress placed on the foot.

Thus, it may be highly desirable to have a system for avoiding and/ortreating the pain of plantar fasciitis. It may also be highly desirableto have a system for treating plantar fasciitis that is economical andmay be easily applied by the patient. It may also be highly desirable tohave a system for treating plantar fasciitis that is discretely attachedto the sole of the patient's foot and includes a substantially stretchresistant material to reduce tensile forces in the plantar fascia.

BRIEF SUMMARY OF THE INVENTION

A preferred embodiment of the present invention provides a system fortreatment of plantar fasciitis. The system is economical and may beeasily applied by a patient.

A stretch resistant plantar fascia support system is provided with afoot sole support. The foot sole support may be a thin one-piece devicemade of a uniform substantially stretch resistant material of a uniformthickness or the foot sole support may be made with a strip ofsubstantially stretch resistant material bounded by a more deformablematerial. The foot sole support may be shaped to conform to the outlineof the bottom of a foot or shaped to cover only a portion of the bottomof a foot. Straps and tabs may be included with the foot sole supportfor providing additional support to both the foot and other portions ofthe stretch resistant plantar fascia support system. The foot solesupport, straps, and tabs have adhesive applied to portions of thesurface of the foot sole support, the straps, and the tabs. Removableprotective covers are applied over the adhesive and the removableprotective covers may include indicia signifying the order in which theportions of the stretch resistant plantar fascia support system are tobe applied to the foot.

To relieve the symptoms of plantar fasciitis, tensile stresses in theplantar fascia are reduced. The tensile stresses in the plantar fasciaare reduced by adhering the foot sole support to the foot of thepatient. The foot sole support absorbs tensile stress in the lower footthereby reducing the tensile stress experienced by the plantar fasciaand surrounding tissues. The straps and tabs may be attached in theprescribed order to the foot sole support and wrapped around or attachedto portions of the foot to provide additional support to the stretchresistant plantar fascia support system.

Certain embodiments of the present invention include an article ofmanufacture that is a kit for at least one of providing anatomicalsupport to the arch of the foot, treating arch pain, treating heel pain,increasing tissue healing and rehabilitation in a human afflicted withplantar fasciitis, and preventing injury to the plantar fascia. The kitincludes a sheet of material having a support layer, an adhesive layerfor applying at least a portion of the support layer to the foot, and acover layer that covers at least a portion of the adhesive layer andthat may be removed from the support layer and adhesive layer. The kitincludes instructions for applying the support layer to the foot for atleast one of supporting the arch, reducing stress on the plantar fasciaor surrounding tissues, and treating plantar fasciitis. The kit includespackaging carrying the sheet and instructions.

Certain embodiments of the present invention include a kit for managingfoot pain. The kit includes a sheet of material configured to be affixedto at least a portion of a foot, the sheet including a stretch resistantsupport layer joined to a cover layer by adhesive, wherein the coverlayer is removed from the adhesive and the support layer is affixed tothe portion of the foot by the adhesive. The kit includes instructionsinstructing how to apply the support layer to the portion of the foot.

Certain embodiments of the present invention include a process forcontrolling stress on a plantar fascia of a foot. The process includesproviding a sheet of material and instructions for using the sheet ofmaterial to control stress on the plantar fascia, wherein the sheet hasa stretch resistant support layer joined to a cover layer by adhesive.The process includes reviewing the instructions, conforming the sheet ofmaterial to the shape of a portion of a foot, removing the cover layerfrom the adhesive and the support layer, applying the support layer tothe portion of the foot such that the adhesive retains the support layerto the portion of the foot, and adjusting the support layer to theportion of the foot where the applying step results in an unsatisfactoryapplication.

Certain embodiments of the present invention include an article ofmanufacture for managing foot pain. The article includes a sheet ofmaterial including a substantially stretch resistant Rayon support layerhaving a thickness of less than 15 mils, an adhesive layer, and arelease liner. The sheet of material is configured to be conformed withcutting tools to the shape of at least a portion of the human foot. Thesupport layer of the conformed sheet is affixed to the foot by theadhesive layer in order to control stress on the plantar fascia orsupport the arch of the foot.

Certain embodiments of the present invention include a sheet of materialhaving a Rayon layer having a nominal thread count of 3600, ahypoallergenic adhesive on the layer, and a release liner affixed to theadhesive. The sheet of material has a thickness of less than 30 mils.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates parts of a plantar fascia in a dissected bottom viewof a human foot.

FIG. 2 illustrates a simplified side view of tissue and bone structurein the human foot.

FIG. 3 illustrates a stretch resistant plantar fascia support system inaccordance with an embodiment of the present invention.

FIG. 4 illustrates a stretch resistant plantar fascia support system inaccordance with an alternative embodiment of the present invention.

FIG. 5 illustrates stresses in the human foot with a stretch resistantplantar fascia support system installed in accordance with an embodimentof the present invention.

FIG. 6 illustrates a top view of a sheet of material containing asupport system in accordance with an embodiment of the presentinvention.

FIG. 7 illustrates an enlarged cross-sectional side view of the sheet ofFIG. 6 taken along line 7-7.

FIG. 8 illustrates a top view of a packaged anatomical foot support kitin accordance with an embodiment of the present invention.

FIG. 9 illustrates a side view of an anatomical foot support kit inaccordance with an embodiment of the present invention.

FIG. 10 illustrates a bottom view of a support system in accordance withan embodiment of the present invention.

FIG. 11 illustrates a top view of a foot having the support system ofFIG. 10 affixed to the foot.

FIG. 12 illustrates a bottom view of the foot and support system of FIG.11 .

FIG. 13 illustrates a side view of the foot and support system of FIG.11 .

FIG. 14 illustrates a rear view of the foot and support system of FIG.11 .

FIG. 15 illustrates a bottom view of a support system in accordance withan embodiment of the present invention.

FIG. 16 illustrates a top view of a foot and the support system of FIG.15 affixed to the foot.

FIG. 17 illustrates a bottom view of the foot and support system of FIG.15 .

FIG. 18 illustrates a side view of the foot and support system of FIG.15 .

FIG. 19 illustrates a bottom view of a foot and a support system inaccordance with an embodiment of the present invention.

FIG. 20 illustrates a top view of a sheet of material containing asupport system in accordance with an embodiment of the presentinvention.

FIG. 21 illustrates a left side view of a foot and a strap affixed tothe foot in accordance with an embodiment of the present invention.

FIG. 22 illustrates a right side view of the foot and strap of FIG. 21 .

FIG. 23 illustrates a side view of a foot and a strap affixed to thefoot in accordance with an embodiment of the present invention.

FIG. 24 illustrates a top view of a sheet of material containing asupport system in accordance with an embodiment of the presentinvention.

FIG. 25 illustrates a side view of a foot and the support system of FIG.24 .

FIG. 26 illustrates a top view of a support system in accordance with anembodiment of the present invention.

FIG. 27 illustrates a front view of a website showing instructionsformed according to an embodiment of the present invention.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

The foregoing summary, as well as the following detailed description ofcertain embodiments of the present invention, will be better understoodwhen read in conjunction with the appended drawings. For the purpose ofillustrating the invention, there is shown in the drawings, certainembodiments. It should be understood, however, that the presentinvention is not limited to the arrangements and instrumentality shownin the attached drawings.

FIG. 3 illustrates a stretch resistant plantar fascia support system 400in accordance with an embodiment of the present invention. The stretchresistant plantar fascia support system 400 includes a foot sole support410, an adhesive layer 411, indicia 415, removable protective covers416, arch straps 420, heel strap 430, heel strap tabs 432, toe strap440, toe strap tab 442, front straps 450, and heel tabs 460.

The arch straps 420, the heel strap 430, the toe strap 440, the frontstraps 450, and the heel tabs 460 are connected to the foot sole support410. The arch straps 420 project from the sides of the foot sole support410 approximately midway along the longitudinal axis of the foot solesupport 410. The heel strap 430 projects from the back edge of the footsole support 410 and the heel strap tabs 432 project from the sides ofthe heel strap 430. The toe strap 440 projects from the front edge ofthe foot sole support 410 and the toe strap tab projects from a side ofthe toe strap 440. The front straps 450 project from the sides of the ofthe foot sole support 410 adjacent the front edge of the foot solesupport 410. The heel tabs 460 project from the sides of the foot solesupport 410 adjacent the back edge of the foot sole support 410.

The adhesive layer 411 is applied to the top or inner surface of thefoot sole support 410, the arch straps 420, the heel strap 430, the toestrap 440, the front straps 450, and the heel tabs 460. The removableprotective covers 416 are removably adhered to the adhesive layer 411.Indicia 415 are printed on the removable protective covers 416.

In operation, the stretch resistant plantar fascia support system 400 isadhesively attached to a human foot 100. To adhesively attach thestretch resistant plantar fascia support system 400 to the human foot100, the removable protective cover 416 adhered to the top of the footsole support 410 is removed. The foot sole support 410 is pressedagainst the outer skin surface 178 on the bottom of the human foot 100.

Adhesion of the foot sole support 410 to the outer skin surface 178 onthe bottom of the human foot 100 prevents extension and stretching oftissue on the bottom of the foot. By restricting extension of the tissueon the bottom of the foot, the level of tensile stress on the plantarfascia is reduced.

In the alternative, adhesive may be applied to select portions of thefoot sole support 410, the straps 420, 430, 440 and 450, and the tabs432, 442, and 462. For example, to reduce the chance of irritation tosensitive skin regions along an arch of the foot or to accommodate userswith high arches, adhesive may only be applied to the portion of thefoot sole support 410 contacting the ball of the foot and the heel ofthe foot.

In another alternative embodiment, adhesive may be applied to the soleof the foot. For example, adhesive sprays may be used to spray anadhesive layer on select portions of the foot. If a strong enoughadhesive spray is used that would hold the foot sole portion 410 inplace, then the stretch resistant plantar fascia support system 400 maybe supplied without the adhesive layer 411 and removable protectivecovers 416.

To help maintain the position of the foot sole support 410 on the bottomof the human foot 100 and further reduce tensile stress on the plantarfascia, the arch straps 420 may be wrapped laterally over the arch ofthe foot. To install the arch straps 420, the removable protective cover416 adhered to the inner surface of the arch straps 420 is removed. Thearch straps 420 are then wrapped up and over the top of the foot 100. Tosecure the arch straps 420 in place, one of the arch straps 420 mayoverlap another arch strap 420 and be adhered to the outer surface ofthe other arch strap 420.

In the alternative, only one arch strap 420 may be used. With only onearch strap 420, the arch strap 420 may wrap laterally over the top ofthe arch and adhere to the bottom surface of the foot sole support 410on the opposite side of the foot 100.

In another alternative embodiment, only one arch strap 420 may be usedand the arch strap 420 may be separate and distinct from the foot solesupport 410. With the foot sole support 410 already installed on thebottom of the foot 100, the arch strap 420 may be adhered to the footsole support 410 on one side of the foot 100. The arch strap 420 maythen be wrapped laterally over the arch, down the opposite side of thefoot 100, and adhered to the foot sole support 410 on the opposite sideof the foot 100.

Installation of the arch straps 420 also reduces stress on the plantarfascia. As presented earlier with regard to FIG. 2 , the stress line 300in FIG. 2 resembles an archer's bow. The stress line 300 passes throughthe talus 162, the navicular 164, the cuneiform 166, and the cuboid 168.Laterally wrapping the arch straps 420 over and around the top of thefoot near the arch provides resistance to vertical and lateral movementof the talus 162, the navicular 164, the cuneiform 166, and the cuboid168. Provision of the resistance to vertical and lateral movement by thearch straps 420 reduces flexure of the “bow” and related changes instress on the plantar fascia.

To provide extra support to the heel of the human foot 100 and helpmaintain the position of the foot sole support 410 on the bottom of thehuman foot 100, the heel strap 430 may be adhered to the heel of thefoot 100. To further support the heel and help maintain the position ofthe foot sole support 410, the heel strap 430 includes heel strap tabs432. To install the heel strap 430 and heel strap tabs 432, theremovable protective cover 416 adhered to the inner surface of the heelstrap 430 and heel strap tabs 432 are removed. The heel strap 430 isthen pressed against the back of the heel of the foot 100 and secured inplace by contact between the adhesive layer 411 and the outer skinsurface 178. The heel strap tabs 432 are pressed against the outer skinsurface 178 along the sides of the heel of the foot 100.

In an alternative embodiment, the stretch resistant plantar fasciasupport system 400 may include a heel strap 430 without heel strap tabs432. The heel strap 430 may be installed as described above by removingthe removable protective cover 416 and adhering the heel strap 430 tothe back of the heel.

Installation of the heel strap 430 provides extra support to the heeland helps maintain the position of the foot sole support 410. Adhesionof the heel strap 430 to the back of the heel provides an anchor pointfor the rear portion of the foot sole support 410. During the course ofwalking, the foot sole support 410 may be subjected to lateral andlongitudinal forces from contact between the foot sole support 410 andother surfaces such as the interior of shoes or floor surfaces.Depending on the level of the lateral and longitudinal forces, theresistance to lateral and longitudinal forces provided by the adhesivelayer 411 may be exceeded. Adhering the heel strap 430 to the heel ofthe foot 100 provides extra resistance to lateral and longitudinalforces that may otherwise cause the foot sole support 410 to shiftaround on the bottom of the foot.

Additionally, the heel strap 430 provides extra support to the heel ofthe foot 100. The human foot has a complex structure of tissue andbones. Tissues in the heel interact with other tissues in the foot totransfer forces exhibited during walking. As shown in FIG. 1 , portionsof the plantar fascia attach to the heel and other tissues that continueup around the back of the heel. Through these attachments, tissues inthe heel transfer forces to and from the plantar fascia. Providing extrasupport to the heel of the foot 100 reduces the amount of stresstransferred between the heel and the plantar fascia.

The stretch resistant plantar fascia support system 400 also includesheel tabs 460. Similar to the heel strap 430, the heel tabs 460 assistin maintaining the position of the foot sole support 410. To install theheel tabs 460, the removable protective covers 416 adhered to the innersurface of the heel tabs 460 are removed. The heel tabs 460 are thenpressed against the sides of the heel of the foot 100 and secured inplace by contact between the adhesive layer 411 and the outer skinsurface 178. As the foot sole support 410 is subjected to lateral andlongitudinal forces, the heel tabs 460 provide additional resistance tothe lateral and longitudinal forces to help maintain the installedposition of the foot sole support 410.

The stretch resistant plantar fascia support system 400 also includesfront straps 450. The front straps 450 assist in maintaining theposition of the foot sole support 410 and provide extra support to thearea near the ball of the foot 100. To install the front straps 450, theremovable protective covers 416 adhered to the inner surface of thefront straps 450 are removed. The front straps 450 are then wrapped upand over the top of the foot 100. To secure the front straps 450 inplace, one of the front straps 450 may overlap another front strap 450and be adhered to the outer surface of the other front strap 450.

In the alternative, only one front strap 450 may be used. With only onefront strap 450, the front strap 450 may wrap laterally over the top ofthe foot 100 and adhere to the bottom surface of the foot sole support410 on the opposite side of the foot 100.

In another alternative embodiment, only one front strap 450 may be usedand the front strap 450 may be separate and distinct from the foot solesupport 410. With the foot sole support 410 already installed on thebottom of the foot 100, the front strap 450 may then be adhered to thefoot sole support 410 on one side of the foot 100. The front strap 450may then be wrapped laterally over the foot 100, down the opposite sideof the foot 100, and adhered to the foot sole support 410 on theopposite side of the foot 100.

During the course of walking, the foot sole support 410 may be subjectedto lateral and longitudinal forces from contact between the foot solesupport 410 and other surfaces such as the interior of shoes or floorsurfaces. Depending on the level of the lateral and longitudinal forces,the resistance to lateral and longitudinal forces provided by theadhesive layer 411 may be exceeded. Adhering the front straps 450 nearthe ball of the foot 100 provides extra resistance to lateral andlongitudinal forces that may otherwise cause the foot sole support 410to shift around on the bottom of the foot.

Installation of the front straps 450 also reduces stress on the plantarfascia. As shown in FIG. 1 , portions of the plantar fascia attach tothe ball of the foot and other portions such as the superficial tracts130 continue past the ball of the foot 100 to the toe region. Due to thecomplex structure of tissue and bones in the human foot, tissues nearthe ball of the foot interact with other tissues in the foot to transferforces induced during walking. Through the attachments near the ball ofthe foot, tissues near the ball of the foot transfer forces to and fromthe plantar fascia 110. Providing extra support near the ball of thefoot 100 reduces the amount of stress transferred between the ball ofthe foot and the plantar fascia 110.

The stretch resistant plantar fascia support system 400 includes a toestrap 440. Installation of the toe strap 440 assists in maintaining theposition of the foot sole support 410. To install the toe strap 440, theremovable protective cover 416 adhered to the inner surface of the toestrap 440 is removed. The toe strap 440 is then pressed against theunderside of the toe and the adhesive layer secures the toe strap 440 inplace.

To further secure the toe strap 440 in place, the toe strap 440 includesa toe strap tab 442. To install the toe strap tab 442, the removableprotective cover 416 adhered to the inner surface of the toe strap tab442 is removed. The toe strap tab 442 is then wrapped up and over thetop of the toe of the foot 100. The toe strap is wrapped back down theopposite side of the toe and adhered to the underside of toe strap 440on the opposite side of the toe.

In the alternative, more than one toe strap tab 442 may be attached tothe toe strap 440. For example, a second toe strap tab may be positionedopposite the toe strap tab shown in FIG. 3 on the opposite side of thetoe strap 440. To install the toe strap tabs 442, the removableprotective cover 416 adhered to the inner surface of the toe strap tabs442 is removed. The toe strap tabs 442 are then wrapped up and over thetop of the toe. To secure the toe strap tabs 442 in place, one of thetoe strap tabs 442 may overlap the other toe strap tab 442 and beadhered to the outer surface of the other toe strap tab 442 similar tothe arch straps 420 shown in FIG. 3 .

In another alternative embodiment, only one toe strap tab 442 may beused and the toe strap tab 442 may be separate and distinct from the toestrap 440 and the foot sole support 410. With the toe strap 440 alreadyinstalled on the bottom of the toe, the toe strap tab 442 may then beadhered to the toe strap 440 on one side of the toe. The toe strap tab442 may then be wrapped laterally over the toe, down the opposite sideof the toe, and adhered to the toe strap 440 on the opposite side of thetoe.

The stretch resistant plantar fascia support system 410 may also includeindicia 415 printed on the removable protective covers 416. The indicia415 may represent instructions for the installation of the stretchresistant plantar fascia support system 410. For example, the indicia415 may be numerical or alphabetic designations for the order in whichportions of the stretch resistant plantar fascia support system 410 areto be installed. In FIG. 3 , the indicia 415 on the removable protectivecover 416 over the foot sole support 410 is the number “1” designatingthat the foot sole support 410 is to be installed first. The indicia 415on the removable protective cover 416 on the arch straps 420 is thenumber “2” designating that the arch straps 420 are the next portion tobe installed. Thus, the indicia may be increased or decreasedincrementally to designate the order in which the portions of thestretch resistant plantar fascia support system 400 are to be installed.

In the alternative, letters or words may be used instead of numerals asthe indicia 415 to designate the order in which the portions of thestretch resistant plantar fascia support system 400 are to be installed.For examples, letters “A”, “B”, and “C” or the words “First”, “Second”,and “Third” may be used to designate the order in which the first threeportions are to be installed.

In the alternative, the indicia 415 may be printed on the variousportions of the stretch resistant plantar fascia support system 400. Forexample, if an adhesive spray is applied to the skin rather than usingan adhesive layer 411 and removable protective covers 416, the indicia415 may be printed on the inner surface of components such as the footsole support 410 and a consumer may still be able to see the indicia anddetermine the order of application.

In an alternative embodiment, the stretch resistant plantar fasciasupport system 400 may include the foot sole support 410 without thearch straps 420, the heel strap 430, the toe strap 440, and front strap450 and the heel tabs 460. Similar to the embodiment shown in FIG. 3 ,the foot sole support 410 would be adhesively applied to the bottomsurface of the foot.

In the alternative, the stretch resistant plantar fascia support system400 may include various combinations of the arch straps 420, the heelstrap 430, the toe strap 440, and front straps 450 and the heel tabs460. For example, an alternative embodiment of the stretch resistantplantar fascia support system 400 may include the foot sole support 410with arch straps 420. Another alternative embodiment of the stretchresistant plantar fascia support system 400 may include the foot solesupport 410 with the heel strap 430. Yet another alternative embodimentof the stretch resistant plantar fascia support system 400 may includethe foot sole support 410 with the toe strap 440. Consequently, variousalternative embodiments of the stretch resistant plantar fascia supportsystem 400 may be used that include the foot sole support 410 withdifferent combinations of the arch straps 420, the heel strap 430, thetoe strap 440, and front strap 450 and the heel tabs 460.

FIG. 4 illustrates a stretch resistant plantar fascia support system 500as an alternative embodiment of the stretch resistant plantar fasciasupport system 400 of FIG. 3 installed on a human foot. The alternativeembodiment shown in FIG. 4 includes a foot sole support 410, arch straps420, heel strap 430, heel strap tabs 432, toe strap 440, and toe straptab 442.

As shown in FIG. 4 , the foot sole support 410 may be adhered to thesole of the foot to provide additional support to the region underneaththe plantar fascia. The arch straps 420 may be wrapped around the top ofthe foot to provide additional support near the arch. The heel strap 430may be adhered to the back of the heel to provide additional support tothe heel and stabilize the position of the foot sole support 410. Thetoe strap 440 may be adhered to the bottom of the toe and the toe strap442 wrapped around the toe to provide additional support to the toe andstabilize the position of the foot sole support 410.

FIG. 5 illustrates stresses in the human foot 100 shown in FIG. 2 with astretch resistant plantar fascia support system 400 attached to thehuman foot 100 in accordance with an embodiment of the presentinvention. As described previously with regard to FIG. 2 , the stressline 300 shows an approximation of the line of forces transferredthrough a foot 100 during typical motion. The stress line 300 resemblesthe shape of an archer's bow. The plantar fascia 110 running along nearthe bottom surface of the foot 100 is analogous to a string in thearcher's bow. Forces that tend to move the ends of the bow apartincrease tension on the string. In other words, as forces on the archpush the bones downward, the plantar fascia 110 is subjected to tensileforces.

To reduce the tensile forces on the plantar fascia 110, the stretchresistant plantar fascia support system 400 is attached to the bottom ofthe foot. As depicted in FIG. 5 , the stretch resistant plantar fasciasupport system 400 is analogous to another string in the archer's bowconnected in parallel with the plantar fascia 110. Tensile forcesinduced in the bottom of the foot are shared between the plantar fascia110 and the stretch resistant plantar fascia support system 400.Consequently, tensile force in the plantar fascia 110 is reduced anddamaged areas may heal with a reduced likelihood of being subjected toexcessive tensile forces.

Thus, a stretch resistant plantar fascia support system using asubstantially stretch resistant material may be conveniently and easilyapplied to the foot of a patient by the patient for the treatment ofplantar fasciitis. For example, the entire foot sole support, orportions of the foot sole support, of the stretch resistant plantarfascia support system may be made of a flexible material that exhibitsless than 15 percent elongation when subjected to a 25 lb tensile loadunder test conditions specified in ASTM D3759. In addition, a materialwith a ratio of elongation to tensile strength (lb/in-width) that isless than 0.9 may be used to provide a balanced combination of strengthand resistance to elongation.

Additionally, to simplify manufacturing and reduce cost, the stretchresistant plantar fascia support system may be made of a uniformmaterial supplied in sheet form. Portions of the stretch resistantplantar fascia support system may be cut or punched from sheets ofmaterial. For example, the foot sole support may be shaped to resemblethe outline of the sole of a left or right foot. Alternatively, the footsole support may also be shaped for interchangeable use on either a leftor right foot.

The stretch resistant plantar fascia support system may then be packagedindividually, in multiples, or in a continuous package such as a rollwith individual patches separated by perforations. For example, theindividual packaging could be used by the average consumer for everydayuse around the home. The continuous packaging could be used in high usesituations such as locker rooms where access to stretch resistantplantar fascia support systems is required by multiple people.

Alternatively, the invention includes an article of manufacture that isan anatomical foot support kit for treating plantar fasciitis and otherkinds of foot pain. The kit includes at least one sheet of stretchresistant material that can be adapted for application to the user'sfoot as a support system to treat plantar fasciitis, instructions thatinstruct the user on how to apply and use the support system, andpackaging that allows for the distribution of the support system andinstructions.

FIG. 6 illustrates a top view of a sheet 500 of material. A supportsystem 504 is formed and removed from the sheet 500 of material for useas the stretch resistant plantar fascia support system on the user'sfoot. The support system 504 is shaped to be applied to the user's footor a portion of the foot. The support system 504 includes a sole portion502 shaped for application to the sole of a foot, a ball strap 506 andheel tabs 510 for retaining the sole portion 502 to the foot or aportion of the foot. Alternatively, support system 504 may be shapedlike the support system 400 shown in FIGS. 3 and 4 or have any number ofother shapes for being connected to the user's foot. The support system504 may be shaped for either a left or a right foot. The support system504 may be pre-cut or perforated into the sheet 500 for the user topunch out of the sheet 500. Alternatively, the user may use cuttingtools to cut the support system 504 from the sheet 500 along an outlineimprinted on the sheet 500 or cut by freehand to suit the user'sparticular foot shape. The sheet 500 may be large enough to include morethan one support system 504. Alternatively, the sheet 500 may be smallersuch that the user may remove multiple smaller portions of a singlesupport system 504 from the sheet 500 for application to the foot. Thesheet 500 may be manufactured by a number of different techniques.Additionally, the sheet 500 may be pre-cut or perforated to form thesupport system 504 by a number of different techniques. By way ofexample only, the sheet 500 may be cut by die-cutting or laser cutting.

FIG. 7 illustrates an enlarged cross-sectional side view of the sheet500 of FIG. 6 taken along lines 7-7. Similar to the support system 400of FIG. 3 , the sheet 500 includes a backing or support layer 508, anadhesive layer 512, and a removable protective cover layer or releaseliner 516. Alternatively, the adhesive layer 512 may be an adhesive thatis applied or coated to the support layer 508. The sheet 500 has agenerally uniform thickness. By way of example only, the sheet 500 mayhave a thickness of up to ⅜ inch. By way of example only, the thicknessof the sheet 500, including all three layers 508, 512, and 516, may beless than 60 mils. By way of example only, the thickness of the sheet500, including all three layers 508, 512, and 516, may be less than 45mils. The relative thicknesses of the layers 508, 512, and 516 may varyfrom each other differently from what is shown in FIG. 7 .

Returning to FIG. 6 , the support layer 508 is made of a material havingthe mechanical integrity to provide support under cyclic loading for theduration of application to the user's foot without excessive elongation,fraying or other forms of degradation. The support layer 508 issufficiently flexible so that it can conform to the shape of the sectionof the foot to which it is adhesively connected and provide structuralsupport to the body part. The material of the support layer 508 may bemade of a single layer or a plurality of layers. By way of example only,the support layer 508 may be less than 15 mils thick and by further wayof example may be less than 5 mils thick. The support layer 508 moreeasily conforms to the shape of the foot where the material of thesupport layer 508 is thinner. Additionally, the support layer 508 mayalso be compliant and non-irritating to the skin of the user.Furthermore, the support layer 508 may be of any color. For example, thesupport layer 508 may be tan or a skin-tone color such that the supportlayer 508 is less visible when applied to the user's foot.

The material of the support layer 508 is substantially stretch resistantin at least one direction. By way of example only, the support layer 508may exhibit less than 15 percent total elongation in at least onedirection when subjected to a 25 lb tensile load under test conditionsspecified in ASTM (American Society for Testing and Materials) D3759. Inaddition, by way of example only, the support layer 508 may have a ratioof elongation to tensile strength (lb/in-width) that is less than 0.9 toprovide a balanced combination of strength and resistance to elongation.By way of example only, the support layer 508 may have a tensilestrength of greater than 10 lb/in-width per ASTM D-1000 and by furtherway of example may have a tensile strength of greater than 20lb/in-width per ASTM D-1000.

The support layer 508 may be manufactured from a wide range of materialssuch as woven and non-woven materials, polymeric materials such asapertured formed thermoplastic films, or apertured plastic films,synthetic or natural fibers, or a combination of materials. By way ofexample only, the support layer may be made of a woven rayon microfiberwith a 3600 thread count and/or thickness of less than 30 mils, oralternatively less than 15 mils, such that the stretch resistant plantarfascia support system is thin enough to comply with the contours of thefoot and strong enough to provide adequate strength.

Additionally, the support layer 508 may be breathable. By way of exampleonly, the support layer 508 may have a moisture vapor transfer rate(MVTR) of at least 100 g/24 h/m·sup·2. By way of example only, thesupport layer 508 may have a MVTR of greater than 400 100 g/24h/m·sup·2.

The adhesive layer 512 includes an adhesive that provides the requisitedegree of adhesion to hold the support layer 508 against the user's footfor the duration of use and is relatively easy to remove at the end ofuse. The adhesive on the adhesive layer 512 is non-toxic andnon-allergenic or hypoallergenic and may or may not be vapor permeable.The adhesive may provide enough tack such that the support layer 508 maybe easily applied and re-adjusted to the foot if necessary. The adhesiveis highly resistant to slippage or movement caused by the potentiallyhigh sheer stresses of the application. By way of example only, theadhesive layer 512 may be less than 10 mils thick, and by further way ofexample may be less than 5 mils thick. By way of example only, theadhesive may provide a holding strength of greater that 15 oz/in whentested according to a PSTC-3 (Pressure sensitive tape council) standardAdhesion-to-Steel 180 degree Peel test. By way of example only, theadhesive may provide a holding strength of greater that 30 oz/in whentested according to the Adhesion-to-Steel 180 degree Peel test.

The release paper 516 is provided over the adhesive layer 512. Therelease paper 516 should remain in place over the adhesive layer 512until removed by the user. By way of example only, the release paper 516may be made of 3.5 mil, 60 #Kraft paper. The release paper 516 mayinclude a tab 518 that can be pulled to easily remove the release paper516 from the adhesive layer 512. Alternatively, to ease removal of thesupport layer 508 of the support system 504 from the release paper 516,the support layer 508 and the adhesive layer 512 that form the shape ofthe support system 504 may not be surrounded by any further supportlayers 508 or adhesive layers 512 on the release paper 516 such thesurrounding release liner 512 is visible about the support system 504.Alternatively, the sheet 500 may be the shape of the support system 504so that the support system 504 does not need to be removed from a largersheet. Thus, the user can simply remove the release paper 516 from thesheet 500 in order to apply the support system 504.

As shown in FIG. 8 , the sheet 500 (or multiple sheets 500) may beprovided in a package 522 for sales or distribution in stacked flatlayers and sealed in a pouch or bag 520 with labeling 524. By way ofexample only, the bag 520 may be cellophane or another suitablematerial. Alternatively, as shown in FIG. 9 , the sheet 500 (or multiplesheets 500) may be packaged by wrapping a plurality of sheets 500 aboutthemselves in the shape of a roll 528. A specific sheet, bearingreference numeral 501, in a roll 528 is connected to an adjacent sheet,bearing reference numeral 502, in the roll 528 along a perforation 532.Alternatively, the user may unroll the sheets 500 and cut adjacentsheets 501 and 502 from each other. Alternatively, the roll 528 mayinclude just one continuous sheet 500 wrapped about itself that the usermay unwrap and cut where appropriate. The roll 528 may include a centerspool (not shown) about which the sheet(s) 500 are wrapped. The roll 528may be packaged in a labeled box or bag, or any number of other kinds ofpackaging.

Alternatively, the sheet 500 or multiple sheets 500 may be packaged inany number of other ways in boxes, bags, envelops, pouches, bottles,jars, cartons, packets, tubes, or any combination thereof or any numberof other forms of packaging.

Returning to FIG. 6 , instructions 536 are included with the sheet 500instructing the user on how to apply and use the sheet 500 as a supportsystem to treat plantar fasciitis. The instructions 536 instruct theuser on how to cut or remove or shape the portion 504 to conform to thefoot, and/or apply the portion 504 of material in a manner intended toprovide anatomical support to the arch of the foot. As shown in FIG. 27, the instructions 536 may also direct the user to a specific computerinternet website 700. The website 700 may provide a set of instructions704 for cutting, removing, shaping and/or applying the portion 504 tothe foot. The instructions 536 may also provide information on, ordirect the user to a website 700 that provides information on, thecauses and treatments of plantar fasciitis, and/or heel pain, and/orarch pain. Furthermore, the set of instructions 536 may contain, ordirect the user to a website 700 that contains, other helpful andcommonly known information regarding diagnosing or treating plantarfasciitis, heal pain and arch pain, including such items as stretchingor therapeutic exercises, which may be used in combination with thesupport system of the sheet 500. The instructions 536 may be provided bya printed statement, indicia (such as alphabetical or numerical indiciasimilar to those shown in FIG. 3 ), a pattern, a photograph, anillustration, or an outline printed separately with, or directly on, thesheet 500 or portion 504. Alternatively, the instructions 536 may beprovided on a brochure, print advertisement, card, manual, leaflet, oran electronic media storage device (such as a compact disc, digitalvideo disc, memory stick, etc.) included in the packaging or theinstructions 536 may be printed directly on the packaging 522 as shownin FIG. 8 . Alternatively, the instructions 536 may be provided by anycombination of the above.

Furthermore, the instructions 536 may direct the user to an interactivewebsite 700 or other media where the user may further learn about thesupport system 504, plantar fasciitis, foot pain, arch pain, heal pain,and treatments and exercises. For example, the website 700 may providethe user with illustrations, descriptions of symptoms, and provideanswers to questions to assist the user in confirming the diagnosis ofplantar fasciitis. The website 700 may have numbered illustrations ofthe foot or sections of the foot that the user can select to describethe location of the pain. The website 700 may provide a questionnaireasking about the user's height, weight, age, flexibility, activities andactivity level, changes in height or activity level, foot type (higharched, normal arched, flat footed), family history of plantarfasciitis, severity of pain, shoe sizes, shoes types and any number ofother topics that will allow the website to advise the user on whetherthe user has plantar fasciitis and/or other kinds of foot pain orinjuries such as a bruised heel, bunion, plantar wart, or any number ofother problems. The website 700 helps the user determine whether theuser actually has plantar fasciitis and thus whether the user should usethe support system 504. People suffering from foot problems other thanplantar fasciitis may not benefit from using the support system 504.

The interactive process of the website 700 provides the user withillustrations and instructions to help the user determine whether theuser should use the support system 504 and determine the best size andshape of the support system 504 for the user to use. The interactiveprocess may further instruct the user as to how to prepare the foot forapplication of the support system 504, such as by shaving or removinghair from the foot and removing oils and lotions from the foot. Theinteractive process may further instruct the user on the temperature atwhich to use the support system 504 and what tension levels areappropriate for use of the support system 504. The interactive processmay further allow the user to chart and report progress in treatingplantar fasciitis and answer questions the user may have during thecourse of the treatment. The interactive process may also providemethods to ease removal of the support system 504.

The website 700 may also educate the user on the causes of stress on theplantar fascia and the factors which may contribute to plantar fasciitissuch that the user may be able to change or alter activities thatirritate or damage the plantar fascia. For example, the website 700 mayinform users who climb stairs for exercise that such a practice maycontribute to plantar fasciitis and provide ways to alter the user'sbehavior so as to reduce inflammation of the plantar fascia.

As part of the interactive process, the website 700 may provide the userwith therapeutic exercises or stretches to perform while using thesupport system 504. Stretches which focus on the plantar fascia may beappropriate in later stages of treatment, and the interactive processmay recommend exercises to the user at the appropriate point in theuser's recovery that will further benefit the recovery. For example,because a biomechanical relationship exists between the calf muscle, theAchilles tendon, and the plantar fascia, the website may recommendexercises to stretch these areas while the user wears the support systemsuch that the stress on the plantar fascia is controlled duringstretching. The website 700 may recommend common calf-stretchingexercises that incorporate the use of an angled board, stairs, a block,or a towel while wearing the support system 504. Examples of suchexercises are described in American Family Physician, Vol. 63, Number 3,pages 469-470, the subject matter of which is incorporated herein byreference.

The interactive process of the website 700 may also suggest a particularshape or size of the support system 504 for the user based on the user'sparticular condition, footwear, or activities. By way of example only,the website 700 may recommend a support system 504 having a straplesssole portion 502 for a woman who wishes to wear open toed shoes. By wayof example only, the website 700 may recommend a support system 504having a sole portion 502, heel tabs 510, a ball strap 506 and anadditional strap (not shown) for the arch of the foot to an overweightuser who places a lot of weight to the arch of the foot. By way ofexample only, the website 700 may recommend a support system 504 havingno straps across the arch of the foot to a runner that wears goodarch-supporting running shoes.

In order to gain access to the interactive website 700, the user may berequired to log-on with a code that is provided with the support system504. Medical professionals such as doctors who are not the end users ofthe support system 504 may be allowed to enter and use the interactivewebsite through separate method of access.

In operation, the user removes a sheet 500 from the packaging 522 ofFIG. 8 . The user may review the instructions 536 that come with thesheet 500 to learn how to apply and use the support system 504. The userremoves or punches or cuts out the support system 504 from the sheet500.

Referring to FIG. 10 , a support system 504 has been removed from thesheet 500. A release liner 516 is separated or perforated into a solesection 542, strap sections 546, and a tab section 550 such thatdifferent sections of the release liner 516 may be removed from thesupport system 504 as necessary. Alternatively, the release liner 516may have any number of sections as necessary to accommodate the shapeand use of the support system 504. After removing the support system 504from the sheet 500, the user may further cut and form the support system504 as necessary for application. For example, the user may trim theheel tab 510 such that the heel tab 510 better fits the user's foot.

Referring to FIGS. 11-14 , a support system 504 is applied to a foot 540or a portion of the foot 540. The user peels the tab section 550 (FIG.10 ) of the release liner 516 (FIG. 7 ) from the heel tab 510 of thesupport system 504 and applies the heel tab 510 of the support layer 508to the heel 554 of the user's foot 540 such that the adhesive layer 512(FIG. 7 ) is affixed to the skin of the user's heel 554 and retains thesupport layer 508 to the heel 554. The user then peels the sole section542 of the release liner 516 from the sole portion 502 of the supportsystem 504 and adhesively applies the sole section 542 of the supportlayer 508 to the sole 558 of the user's foot 540. The sole portion 502should be positioned about the sole 558 of the foot 540 from the bottom566 of the heel 554 along a longitudinal axis 570 axis of the foot 540to the ball 574 of the foot 540. The user then peels the strap sections546 of the release liner 516 from the ball strap 506 of the supportsystem 504 and adhesively applies the ball strap 506 of the supportlayer 508 transversely to the longitudinal axis 570 of the foot 540across the sole 558 of the foot 540 about the sides 560 and top 562 ofthe user's foot 540 to secure the sole portion 502 about the sole 558.Thus, the multiple sections of the release liner 516 allow the user touse the heel tab 510 as an anchoring connection to the foot 540 suchthat the sole section 542 and the ball strap 506 may be more easilyaligned and affixed to the foot 540 than if the entire support layer 508was applied to the foot 540 at once. The user may remove and re-apply oradjust the support layer 508 on the foot 540 to obtain a betterplacement. Once the support layer 508 has been secured to the foot 540as shown in FIGS. 11-14 , the support layer 508 may be worn all day longand changed on a daily basis. The support system 504 may be usedcontinuously or on a periodic basis as needed. Once each support layer508 has been used, the user removes and disposes of the support layer508 and reapplies a new support layer 508. The support layer 508 may beused with orthotic practices, physical therapy, and other treatmentmodalities to treat plantar fasciitis and other foot pain.

Alternatively, the support system may have any number of differentconfigurations for use with a foot. Referring to FIG. 15 , a supportsystem 804 includes an additional arch strap 578 having first and secondends 582 and 586 extending transversely from the sole portion 502. FIGS.16-18 illustrate multiple views of the support system 804 of FIG. 15applied to a foot 540. The support system 804 is applied to the foot 540in generally the same manner as the support system of FIGS. 11-14 .However, the user also adhesively applies the arch strap 578 of thesupport layer 508 transversely to the longitudinal axis 570 and arch 590of the foot 540 across the sole 558 of the foot 540 and about the sides560 and top 562 of the user's foot 540 such that the first and secondends 582 and 586 may or may not overlap and are adhesively connected atthe top 562 of the user's foot 540. The embodiment of the support system804 with the arch strap 578 provides additional support along the arch590 of the foot 540.

Referring to FIG. 19 , a support system 904 may include a strapless soleportion 502 that is adhesively applied to the entire sole 558 of thefoot 540 from the bottom 566 of the heel 554 along the longitudinal axis570 axis of the foot 540 to the ball 574 of the foot 540. Alternatively,the sole portion 502 may only cover a portion of the sole 558. Becausethe support system 904 does not include any straps, users may discretelywear the support system 904 with shoes that reveal the top and sides ofthe user's foot, such as sandals or other open shoes.

Alternatively, as shown in FIG. 20 , the support system 940 may includeseparate portions that can be removed from the sheet 500. The supportsystem 940 includes the sole portion 502 with heel tabs 510, the ballstrap 506, and the arch strap 578, each of which can be removedseparately from the sheet 500 for application to the foot 540. Forexample, the user may apply the sole portion 502 first, and then applyeither or both of the ball strap 506 and the arch strap 578 as the usersees fit. Alternatively, the user may only apply one of the sole portion502, the ball strap 506 or the arch strap 578, or any combinationthereof. Thus, the embodiment of FIG. 20 offers the user moreflexibility in tailoring the treatment to the user's specific needs fortreating pain while limiting the visibility of the support system 940.

Alternatively, the support system may include a single strap that theuser can use in combination with orthotic practices to address specificpain problems. The strap may be sized and shaped to address theparticular areas of the user's foot that need treatment. FIGS. 21 and 22illustrate opposite side views of a strap 594 applied to a foot 540. Thesingle strap 594 may be applied to the foot 540 transversely to the arch590 and longitudinal axis 570 of the foot 540 from ankle 598 to ankle602. The strap 594 provides constant pressure along the arch 590 of thefoot 540 to reduce inflammation and thus reduces pain. The strap 594 maybe worn at night when the user sleeps. Alternatively, as shown in FIG.23 , the strap 594 may include a support strap 606 configured to holdthe strap 594 about the ankles 598 and 602. By way of example only, thesupport strap 606 may be retained about the leg 610 by adhesive,elastic, or Velcro.

FIG. 24 illustrates a top view of a diamond-shaped strap 614 that may beprovided on a sheet 500 as part of a support system according to anembodiment of the present invention. As shown in FIG. 25 , the strap 614may be applied to the foot 540 transversely to the longitudinal axis 570and arch 590 of the foot 540 across the sole 558 of the foot 540 andabout the sides 560 and top 562 of the user's foot 540 like the archstrap 578 of FIG. 15 . The strap 614 anatomically supports the medialarch of the foot 540 instead of specifically to the longitudinal arch.

FIG. 26 illustrates a top view of the support system 980 in accordancewith an embodiment of the present invention. The support system 504includes holes 618 along the ball strap 506 and heel tabs 510 and slots622 and a tear-shaped aperture 626 along the sole portion 502.Alternatively, the support system 980 may include any number ofapertures having other shapes. Alternatively, the support system 504 mayhave at least one of, or any combination of, the holes 618, slots 622and aperture 626 at any other locations thereon. The holes 618, slots622, and aperture 626 are provided to alter the stretch resistantproperties of the support system 980, focus or transfer the stresscarried by the support system 980, or aid in preventing directapplication of pressure to inflamed areas of the foot when the supportlayer 508 of the support system 980 is applied to the user's foot. Also,the holes 618, slots 622, and aperture 626 allow the skin from the footto breathe and allow the skin to contact surfaces in order to reduce thepossibility of the user slipping while wearing the support system 980.Additionally, the holes 618, slots 622, and aperture 6226, may beornamental. The holes 618, slots 622, and aperture 626 may be pre-cutinto the support system 980 or may be created by the user.

Like the support system 400 of FIG. 3 , the foot support kit serves torestrict extension of the tissue on the bottom of the foot and thus thelevel of tensile stress on the plantar fascia to reduce foot pain, archpain, and heel pain, and to rehabilitate the plantar fascia, and toprevent injury to the plantar fascia. The stretch resistant propertiesof the support layer 508 share the stresses normally absorbed by theplantar fascia alone. The support layer 508 manages foot pain andaddresses the cause of plantar fasciitis by controlling and limiting thestress on the plantar fascia and surrounding tissues across both themedial and longitudinal arches and thus minimizes tears in the plantarfascia.

The stretch resistant plantar fascia support system of the differentembodiments may be used while sleeping, while walking around withbarefeet, or while wearing various types of footwear. Also, the stretchresistant plantar fascia support system non-invasively reduces the levelof tensile stress carried by the plantar fascia and may prevent the needfor complex and expensive surgery.

For example, a consumer may wake-up in the morning and experience painalong the bottom of the consumer's foot. The consumer may recognize thepain as plantar fasciitis and desire to treat the pain. Rather thanschedule an appointment with a doctor and have to travel to the doctor'soffice for treatment, during which time the plantar fascia may besubjected to further excessive tensile stress, the consumer may desireto treat the pain at home.

With the stretch resistant plantar fascia support system of the presentinvention, the consumer may save the time, expense, and pain oftraveling to a doctor's office for treatment. To use the stretchresistant plantar fascia support system, the consumer would simplyremove the removable protective covers that protect the adhesive layerand apply the stretch resistant plantar fascia support system to theaffected area.

While the above scenario described the consumer applying the stretchresistant plantar fascia support after waking up in the morning, thestretch resistant plantar fascia support system may also be worn to bedat night. By wearing the stretch resistant plantar fascia support systemto bed at night, the stretch resistant plantar fascia support system mayaid in the healing process while the consumer sleeps and protects theplantar fascia during the first few steps in the morning when stress isre-applied.

In addition, the stretch resistant plantar fascia support system may becomfortably worn when the consumer is not currently experiencing pain,but anticipates the potential for injury during a strenuous activity.For example, a consumer with a history of frequent occurrences ofplantar fasciitis may desire to return to a strict exercise regimentfollowing a prolonged period of inactivity. To avoid overstressing theplantar fascia until the foot has had enough time to becomere-accustomed to the stresses of exercise, the consumer may desire touse the easily applied stretch resistant plantar fascia support systemrather than some of the more cumbersome, less effective, andinconvenient alternatives such as taping and molded arch supports.

To aid the consumer with installation of the stretch resistant plantarfascia support system, the removable protective covers, or otherportions of the stretch resistant plantar fascia support system, mayinclude numerical indicia that indicate the order in which portions ofthe stretch resistant plantar fascia support system are applied to thefoot. The consumer then applies the stretch resistant plantar fasciasupport system to the consumer's foot in the prescribed order.

In addition, the stretch resistant plantar fascia support system iscomfortable and form fitting. The stretch resistant plantar fasciasupport system may be supplied for a plurality of foot sizes and theconsumer may select the stretch resistant plantar fascia support systemmuch like shoes are selected based upon standard shoe sizes. The footsole support of the stretch resistant plantar fascia support system mayeven be shaped to conform to the shape of the sole of a foot. If anadjustment is needed to adapt the stretch resistant plantar fasciasupport system to an irregularity in a particular consumer's foot, thestretch resistant plantar fascia support system may be easily adapted bycutting the stretch resistant plantar fascia support system toaccommodate the irregularity.

Because the stretch resistant plantar fascia support system is formfitting, the consumer may wear the stretch resistant plantar fasciasupport system in a variety of situations. For example, if a woven rayonmicrofiber with a 3600 thread count and/or thickness less than 30 mils,or alternatively less than 15 mils, is used, then the stretch resistantplantar fascia support system is thin enough to comply with contours ofthe foot and strong enough to provide adequate strength. While theconsumer has the stretch resistant plantar fascia support systemattached to the consumer's foot, the consumer has the option of walkingaround in bare feet, pulling a sock over the foot, or putting on shoes.The consumer may also wear the stretch resistant plantar fascia supportsystem while using other additional devices such as arch supports, nightsplints, and custom orthotics.

Also, the stretch resistant plantar fascia support system does notinterfere with rotation and movement of the ankle or calves. The stretchresistant plantar fascia support system is positioned beneath the ankle.The heel straps and the heel strap tabs are sized to avoid interferencewith the ankle bone. Because the stretch resistant plantar fasciasupport system is positioned beneath the ankle, contact between adhesiveand leg hair is reduced. Thus, the need for shaving portions of the legand ankle is reduced.

Also, different embodiments of the stretch resistant plantar fasciasupport system may be used depending on the type of footwear theconsumer desires to wear while the stretch resistant plantar fasciasupport system is attached. For example, if the consumer is going towear sandals, the consumer may desire to use a stretch resistant plantarfascia support system with a foot sole support and no adhesive straps ortabs to reduce the visibility of the stretch resistant plantar fasciasupport system. On the other hand, the consumer may desire to wearboots, where visibility of the stretch resistant plantar fascia supportsystem is not an issue, and the consumer desires to have straps and tabsalong with the foot sole portion for added stability.

The present invention may also include other items that can benefit auser. For example, to minimize the potential for skin damage and footodor from the presence of moisture, the stretch resistant plantar fasciasupport system may be made of a permeable material. The stretchresistant plantar fascia support system may be made of a permeablematerial that wicks moisture away from the skin or the stretch resistantplantar fascia support system may include holes in the material to allowfor the evaporation of moisture. In conjunction with the permeablematerial, adhesive may be applied in an intermittent manner to furtherincrease the permeability and reduce the presence of moisture trappedbetween the foot and the stretch resistant plantar fascia supportsystem. Also, the stretch resistant plantar fascia support system mayinclude additives such as medicines, anti-fungal treatments,anti-microbial treatments, anti-inflammatory treatments, coolingcompounds, heating compounds, deodorants, zeolite, perfumes,moisturizers, tee tree oil, talcum powder, and zinc oxide.

Thus, the present invention provides an effective system for thetreatment of plantar fasciitis that is both economical and easy to use.The present invention provides a stretch resistant system that may bediscretely attached to a patient's foot and reduces stress on theplantar fascia.

While the invention has been described with reference to certainembodiments, it will be understood by those skilled in the art thatvarious changes may be made and equivalents may be substituted withoutdeparting from the scope of the invention. In addition, manymodifications may be made to adapt a particular situation or material tothe teachings of the invention without departing from its scope.Therefore, it is intended that the invention not be limited to theparticular embodiment disclosed, but that the invention will include allembodiments falling within the scope of the appended claims.

1.-25. (canceled)
 26. An article of manufacture suitable for addressinga problem in a human body, the article of manufacture comprising: amaterial in sheet form including first and second adhesive-coated partsreleasably retained on a cover layer, wherein each of the first andsecond adhesive-coated parts includes: a support layer of syntheticmicrofiber fabric having a greater resistance to stretching in a firsttest direction of two test directions specified in ASTM (AmericanSociety for Testing and Materials) D3759 than in a second test directionof the two test directions; and an adhesive intermittent across thesupport layer; said first adhesive-coated part being elongated withstraight sides and rounded end portions, and being configured to beremovable from said cover layer and adhered to an outer skin surface ofthe human body; and said second adhesive-coated part being elongatedwith straight sides and rounded end portions, and configured to beremovable from said cover layer and adhered to the outer skin surface ofthe human body independently from the first part; wherein the supportlayer allows the passage of moisture vapor and the adhesive beingintermittent across the support layer increases permeability.
 27. Thearticle of manufacture of claim 26, wherein the support layer isconfigured to wick moisture away from an outer skin layer of the humanbody.
 28. The article of manufacture of claim 26 wherein the supportlayer has a thickness that is less than 30 mils and a tensile strengththat is greater than 10 lb/in-width.
 29. The article of manufacture ofclaim 26, wherein the synthetic microfiber fabric includes Rayon. 30.The article of manufacture of claim 26, wherein the synthetic microfiberfabric includes woven fabric.
 31. The article of manufacture of claim26, wherein the synthetic microfiber fabric is a breathable fabric. 32.The article of manufacture of claim 26, wherein the synthetic microfiberfabric is a moisture-wicking fabric.
 33. The article of manufacture ofclaim 26, wherein the synthetic microfiber fabric has a moisture vaportransfer rate (MVTR) of at least 100 g/24 h/m².
 34. The article ofmanufacture of claim 26, wherein the support layer has a ratio ofelongation in percent to tensile strength (lb/in-width) that is lessthan 0.9 in one of the two test directions, and greater than 0.9 in theother of the two test directions, wherein elongation and tensilestrength are determined in accordance with ASTM D3759.
 35. The articleof manufacture of claim 26, wherein the support layer has a tensilestrength of greater than 20 lb/in-width.
 36. The article of manufactureof claim 26, wherein the support layer exhibits less than 15% elongationwhen subjected to a 25 lb tensile load one of the two test directions.37. The article of manufacture of claim 26, wherein the adhesiveincludes a hypoallergenic adhesive.
 38. The article of manufacture ofclaim 26, wherein the adhesive has a holding strength of greater than 15oz/in.
 39. The article of manufacture of claim 26, further comprising: apackage containing the material.
 40. The article of manufacture of claim39, wherein the material is formed in a roll in the package.
 41. Thearticle of manufacture of claim 40, further comprising a center spoolwithin the roll.
 42. The article of manufacture of claim 39, wherein thematerial is one continuous sheet.
 43. The article of manufacture ofclaim 39, wherein the package includes a tube.
 44. The article ofmanufacture of claim 39, wherein the package contains a stack of sheetsof the material.
 45. The article of manufacture of claim 39, wherein allcompleted parts within the package are of similar shape.
 46. The articleof manufacture of claim 39, wherein the package further includes atleast a third adhesive-coated part.
 47. The article of manufacture ofclaim 26, wherein the first adhesive-coated part is an elongated strap.48. The article of manufacture of claim 26, wherein the firstadhesive-coated part and the second adhesive-coated part comprise aplurality of precut elongated strips.
 49. The article of manufacture ofclaim 26, wherein the first adhesive-coated part and the secondadhesive-coated part have a uniform thickness.
 50. An article ofmanufacture suitable for addressing a problem associated with a humanbody, the article of manufacture comprising: a material in sheet formincluding first and second adhesive-coated parts releasably retained ona cover layer, wherein the material includes: a support layer ofsynthetic microfiber fabric having a greater resistance to stretching ina first test direction of two test directions specified in ASTM(American Society for Testing and Materials) D3759 than in a second testdirection of the two test directions; and an adhesive intermittentacross the support layer; said first adhesive-coated part beingelongated straight sides and with rounded portions and configured to beremovable from said cover layer and adhesively applied to the humanbody; and said second adhesive-coated part being elongated andconfigured to be removable from said cover layer and adhesively appliedto the human body; wherein the support layer allows the passage ofmoisture vapor and the adhesive being intermittent across the supportlayer increases permeability.